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Accuracy of insulin-like growth factor binding protein-1/alpha-fetoprotein in diagnosing ruptured fetal membranes

Accuracy of insulin-like growth factor binding protein-1/alpha-fetoprotein (AmnioQuick Duo) in diagnosing ruptured fetal membranes

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001891213
Enrollment
245
Registered
2018-11-21
Start date
2019-01-01
Completion date
2020-01-01
Last updated
2021-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Pregnant women between 20-40 years old, diagnosed as preterm premature rupture of membranes or premature rupture of membranes will constitute the study group and women admitted for control of blood pressure and/or diabetes with pregnancy after more than or equal 24 and less than 39 weeks will constitute the control group. After thorough history, studied women will be examined by trans-abdominal sonography (TAS) for evaluation of the amniotic fluid index, followed by sterile vaginal speculum examination to detect leaking amniotic fluid and for collection of samples for fern, and/or nitrazine and AmnioQuick® Duo test on admission. The final diagnosis of whether the studied women had ruptured fetal membranes or not at the initial presentation will be made after delivery.

Interventions

Inclusion criteria includes; pregnant women between 20-40 years old, diagnosed as preterm premature rupture of membranes (more than or equal 24 and less than 34 weeks admitted for conservative treatment) or premature rupture of membranes (more than or equal 34 and less than 39 weeks` admitted for delivery) as study group. After thorough history, studied women will be examined by the gynaecologist on-call using trans-abdominal sonography for evaluation of the amniotic fluid index, followed by

Inclusion criteria includes; pregnant women between 20-40 years old, diagnosed as preterm premature rupture of membranes (more than or equal 24 and less than 34 weeks admitted for conservative treatment) or premature rupture of membranes (more than or equal 34 and less than 39 weeks` admitted for delivery) as study group. After thorough history, studied women will be examined by the gynaecologist on-call using trans-abdominal sonography for evaluation of the amniotic fluid index, followed by sterile vaginal speculum examination to detect leaking amniotic fluid and for collection of samples for fern, and/or nitrazine and AmnioQuick Duo test on admission. In addition; maternal temperature and pulse rate, fetal hart rate will be checked by the maternity ward nurse, followed by specific laboratory investigations as; maternal total leucocyte count, C-reactive proteins and pro-calcitonin to exclude chorioamnionitis. Studied women will be examined in Lithotomy position with proper illumination by the gynaecologist on-call for samples collection using sterile vaginal speculum. Sterile swabs will be used to collect the samples from the posterior vaginal fornix. The first nitrazine yellow swab will be inserted for 15 seconds in the posterior vaginal fornix and then the colour of the swab will be checked. The sample of the fluid collected from the posterior vaginal fornix using the second swab will be spreaded on a glass slide, creating a thin smear and will be examined by low power microscope (fern test). Insulin growth factor binding-protein-1/ alpha fetoprotein (AmnioQuick Duo) will be done following the manufacturer's instructions. Third Nylon swab supplied in the AmnioQuick Duo (Biosynex, Strasbourg, France) kit package will be inserted in the posterior fornix of the vagina for 1 minute. Then, the swab will be removed, inserted into a unit dose vial containing solvent and rotated for 10 seconds into the solvent. Three drops of the extracted substance from the swab by the solvent will be dispensed into a round sample well of the test device. The result interpreted in 10 minutes. The test positive when both C and B lines present or when both A and C lines present. The test negative when both A and B lines absent. Test invalid when no visible purple band at line C. The final diagnosis of whether the studied women had ruptured fetal membranes or not at the initial presentation will be made after delivery. After delivery, the recorded data of admission and delivery will be compared to evaluate the accuracy of the insulin-like growth factor binding protein-1/alpha-fetoprotein (AmnioQuick Duo) in diagnosing ruptured fetal membranes.

Sponsors

Ibrahim A. Abdelazim
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Primary purpose
Diagnosis

Eligibility

Sex/Gender
All
Age
20 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

Inclusion criteria includes; pregnant women between 20-40 years old, diagnosed as preterm premature rupture of membranes (more than or equal 24 and less than 34 weeks admitted for conservative treatment) or premature rupture of membranes (more than or equal 34 and less than 39 weeks` admitted for delivery) as study group.

Exclusion criteria

Exclusion criteria includes; rupture of membranes less than 24 weeks` or more than or equal 39 weeks` or prolonged rupture of membranes (more than 12 hours) or non-reassuring fetal cardio-tocography, multiple pregnancies, ante-partum hemorrhage, preterm labour and infection of fetal membranes (chorioamnionitis).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026